China NMPA Drug Inspection - Sichuan Pharmaceutical Co., Ltd. - Scrophularia

The Sichuan Provincial Drug Administration published its Third Issue Drug Quality Bulletin on July 22, 2019, detailing findings from recent sampling inspections across various drug production, distribution, and use units. The inspections, conducted under the Sichuan Province Drug Sampling Work Plan and guided by regulatory frameworks such as the Chinese Pharmacopoeia (2010 and 2015 editions), identified 44 batches of non-compliant drugs.

Multiple pharmaceutical manufacturers and distributors were implicated, with key issues spanning a range of products, predominantly Traditional Chinese Medicine (TCM) decoction pieces and preparations, but also chemical drugs like Acetaminophen. Common violations included failures in "Properties" (e.g., appearance, integrity), "Content Determination" (indicating incorrect active ingredient levels or potency, affecting drugs like Epimedium, Safflower, and Honeysuckle), "Identification" (microscopic or chromatographic verification), and "Inspection" items such as moisture content, pack weight difference, total ash, impurities, heavy metals (e.g., arsenic in Leech), and pesticide residues (e.g., in American Ginseng).

In response to these findings, the regulatory body mandated that the responsible enterprises immediately suspend sales and use of the non-compliant products, initiate recalls, thoroughly investigate the root causes of non-compliance, and implement comprehensive rectification measures to ensure future adherence to quality standards.